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Calcifidol Therapy in Men With Cancer
This study has been completed.
Study NCT00018538   Information provided by Department of Veterans Affairs
First Received: July 3, 2001   Last Updated: January 20, 2009   History of Changes

July 3, 2001
January 20, 2009
October 1999
 
 
 
Complete list of historical versions of study NCT00018538 on ClinicalTrials.gov Archive Site
 
 
 
Calcifidol Therapy in Men With Cancer
Calcifidol Therapy in Men With Cancer

Prostate cancer is a common occurrence in the aging population, with one in ten men destined to develop the disease. 40% of patients with prostate cancer experience a recurrence after definitive treatment. This study addresses the as-yet unresolved problem of the optimal management of early recurrence as manifested by increase in the accepted marker for this disease, PSA. Vitamin D, an agent with cell-differentiating properties, has been shown to inhibit angiogenesis and cause differentiation of prostate cancer cells in the laboratory and to affect PSA favorably in clinical studies of patients with advanced prostate cancer. This study will assess the effects of vitamin D in patients with sub-clinical biochemical relapses of prostate cancer as indicated by rising PSA but low tumor burdens, with the potential for developing an approach to this problem that will delay or prevent progression.

 
Phase II
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Prostate Cancer
Drug: calcifidiol
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
September 2002
 

Patients will be males with three successive rises in PSA after achieving a nadir post-definitive therapy. The following criteria must be met: pathologically confirmed prostate cancer, completion of definitive treatment in the form of local external beam radiation or definitive surgery and three successive rises in PSA with no clinical evidence of disease.

Male
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00018538
 
ONCO-09-99S
Department of Veterans Affairs
 
Investigator: Guy Howard, Ph.D
Investigator: Gary Schwartz, Ph.D, MPH
Investigator: James Schlesselman, Ph.D
Department of Veterans Affairs
December 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP